Intranasal Mometasone Furoate Research Articles

May Hyperbaric Oxygen Therapy Play a Role in the Treatment of Allergic Rhinitis? A Double- Blind Experimental Study in Rat Model Hyperbaric Oxygen Therapy on Allergic Rhinitis

Objectives: Medical treatments may be inadequate for the management of allergic rhinitis. Therefore, it requires different treatment options. We aimed to evaluate the effects of nasal steroid and hyperbaric oxygen (HBO) treatments on the nasal mucosa of an allergic rhinitis of a (AR) rat model. Methods: Group 1 (control group); Group 2 toluene diisocyanate (TDI) group; Group 3 was exposed to TDI and treated with HBO; Group 4 was exposed to TDI and treated with intranasalmometasone furoate. After the sacrification, the sections were then evaluated semi-quantitatively and parameters of histopathological inflammation, fibrosis and eosinophilia were assessed. Results: The level of inflammation in the control group was significantly less severe than Group 2. There were statistically significant differences between Groups 2, 3 and 4. Evaluation of thefibrosis scores showed that the scores of Group 4 were significantly higher. Group 1 has significantly lower eosinophil counts than the other groups. Group 2 has significantly higher eosinophil counts than group 4. Conclusion: Anti-inflammatory effects of both nasal steroid and HBO treatments were found to be similar in our study. Nasal steroid therapy combined with HBO therapy may be used on treatmentresistant patients with persistent AR.

Effects of propolis in an experimental rat model of allergic rhinitis

PurposeThe aim of this study was to determine the anti-allergic activity of propolis in an ovalbumin-induced rat model of allergic rhinitis. Materials and methodsThis prospective experimental study was conducted at Hakan Çetinsaya Clinical and Experimental Animal Research Center with 30 rats. After sensitization of all rats with 0.3mg intraperitoneal ovalbumin plus 30mg aluminum hydroxide for 14days (first phase), rats were divided to five groups. In the second phase of the study 10μL of ovalbumin was applied to each nostril for 21days. Together with second phase, ketotifen (n:6), oral propolis (n:6), intranasal propolis (n:6) and intranasal mometasone furoate (n:6) were given to rats. A control group (n:4)(salin) and sham group (n:2) were planned. Symptoms were assessed on days 19, 22, 25, 30 and 35, resulting in 5 symptom scores: symptom scores 1–5. On day 35, nasal tissue was removed and histological examination was performed. ResultsWhen rats that received systemic and intranasal propolis were compared to controls, ciliary loss, inflammation, increase in goblet cells, vascular proliferation, eosinophil count, chondrocytes and allergic rhinitis symptom score were found to be decreased (p<0.05). ConclusionsIt was found that propolis had anti-allergic effects on allergic symptom scores and nasal histology.

Comparison of Histopathological Effects of Thymoquinone and Local Nasal Corticosteroids in Allergic Rhinitis in a Rabbit Model

Background/Aims: In this study, we aimed to evaluate the histopathological effects of thymoquinone treatment of the nasal mucosa in a rabbit model of allergic rhinitis, and we compared its effects with those of nasal mometasone furoate. Methods: A total of 24 male New Zealand rabbits were used. The animals were randomly assigned to one of four groups. Group 1 received no treatment, while group 2 underwent ovalbumin (OVA) sensitization only. Group 3 was the study group; after OVA sensitization, the rabbits were treated with intranasal thymoquinone. The group 4 rabbits received mometasone furoate for 7 days after OVA sensitization. Mucosal structures were stained with hematoxylin and eosin, while toluidine blue was used to stain mast cells. Apoptosis was evaluated using a TUNEL assay. Results: In the positive control groups, including the thymoquinone and intranasal mometasone furoate groups, intraepithelial and submucosal inflammation and goblet cell hypertrophy were significantly decreased compared to group 2 (p < 0.001). The cilial structure was normal, as was the chondrocyte structure in both treatment groups. Conclusion: This is the first study to evaluate the histopathological effects of thymoquinone in an allergic rhinitis model. Thymoquinone reduced allergic inflammation and may be valuable for treating allergic rhinitis. However, additional studies are needed.

Nasal fluid secretory immunoglobulin A levels in children with allergic rhinitis

ObjectivesThere is growing knowledge about the immunoregulatory and possibly preventative roles of immunoglobulin A (IgA) in allergic diseases. This study aimed to investigate secretory immunoglobulin A (SIgA) levels in the nasal fluid of children who were either being treated for their allergic rhinitis (AR) with intranasal mometasone furoate or were not receiving treatment. MethodsThe study population contained 55 children with persistent AR. Group I included 27 newly diagnosed AR patients not taking any medication and group II included 28 patients treated with intranasal steroids for at least 6 months. 27 healthy control subjects were also enrolled in the study. Total symptom scores (TSS) were calculated for each patient. Nasal secretions were obtained using a new modified polyurethane sponge absorption method, and samples were analysed by ELISA. ResultsThe median value for nasal fluid SIgA level in each group was 127.2μg/ml (interquartile range; 67.3–149.6) in group I, 133.9μg/ml (102.1–177.8) in group II and 299.8μg/ml (144.5–414.0) in the control group. Groups I and II both had statistically significant reductions in nasal fluid SIgA levels compared to the control group (p<0.001). However, there was no statistically significant difference between groups I and II (p=0.35). A statistically significant and negative correlation also existed between TSS and nasal fluid SIgA levels in both groups I and II (p=0.006, rho=−0.512 and p=0.01, rho=−0.481, respectively). ConclusionsSIgA levels in the nasal fluid are significantly reduced in children with AR independent of treatment and are negatively correlated with the TSS.

A comparative study of the efficacy of topical nasal steroids versus systemic steroids in the treatment of otitis media with effusion in children

Abstract To evaluate the effectiveness of using topical nasal steroids versus oral steroids in the treatment of otitis media with effusion (OME) in children. One hundred (100) patients were included in the study, they were divided into two equal groups, group A received intranasal mometasone furoate spray once daily for 6 weeks, and group B received oral steroids in tapering doses for 6 weeks, plus systemic antibiotics, and nasal decongestants for both groups, tympanogram was done every 2 weeks for all patients. Highly significant improvement (P 0.05) in improvement between the two groups. Both topical intranasal and oral steroids are effective medical therapy in the treatment of OME in children with no significant difference between the two methods.

Intranasal corticosteroids for mild childhood obstructive sleep apnea – a randomized, placebo-controlled study

BackgroundThe use of non-surgical treatment for childhood obstructive sleep apnea (OSA) is gaining popularity, especially in children with mild disease. ObjectiveTo test the hypothesis that intranasal corticosteroids reduce disease severity in children with mild OSA. Study designA randomized, double-blinded, placebo-controlled trial of intranasal mometasone furoate (MF) versus placebo in children aged 6 to 18 years with mild OSA. The primary outcome was the change from baseline obstructive apnea hypopnea index (OAHI), as documented by overnight polysomnography, after four months of treatment. ResultsSixty-two children were recruited but 12 dropped out. This left 24 and 26 children for final analysis in the MF and placebo group, respectively. The OAHI and oxygen desaturation index (ODI) improved significantly in the MF group only. The OAHI decreased from 2.7 ± 0.2 to 1.7 ± 0.3 in the MF group, but increased from 2.5 ± 0.2 to 2.9 ± 0.6 in the placebo group (p = 0.039). The mean changes in ODI in the MF group and placebo group were −0.6 ± 0.5 and +0.7 ± 0.4, respectively (p = 0.037). ConclusionFour months of treatment with intranasal mometasone furoate effectively reduces the severity of mild OSA in children.

Comparison of Mometazon Furoate to Cetirizin for Symptom Severity Control and QOL in Allergic Rhinitis

Objectives: Evaluate and compare nasal symptom scores and quality of life (QOL) findings in allergic rhinitis patients. Methods: A total of 426 adult allergic rhinitis patients’ medical records were evaluated retrospectively. Group A consisted of 188 patients and received mometasone furoate nasal spray (100 mcg daily/nostril). Group B consisted of 238 patients receiving cetirizine (10 mg oral/daily) for 30 days. Nasal symptoms (watery discharge from the nose, nasal congestion, sneezing and nasal pruritus) and QOL (Short Form-36) were recorded before and after treatment. Results: When compared before and after treatment, each group’s total nasal symptom scores reduced significantly (Group A, P = .001; Group B, P = .002), and QOL scores improved significantly (Group A, P = .001, Group B, P = .001). But when compared between groups, Group A results were better than Group B (total nasal symptom scores P = .001, QOL scores P = .003). Conclusions: Although intranasal mometasone furoate is a better choice than oral cetirizine, both of these medicines can be used to control allergic rhinitis symptoms and improve patient QOL.

The Efficacy of Mometasone Furoate Nasal Spray in the Treatment of Adenoidal Hypertrophy in Children

Objectives: Realize whether the adenoid size and severity of chronic nasal obstruction symptoms may decrease with intranasal mometasone furoate application in children affected with adenoidal hypertrophy. Methods: Forty children with severe adenoidal hypertrophy (aged between 4-12 years) were recruited between August 2012 and April 2013 in a prospective randomized clinical trial. Primary nasal endoscopy showed more than 75% choanal obstruction in all patients. Subjects were randomly divided into 2 groups. The study group (n = 20) underwent mometasone nasal spray treatment (100 micrograms per nostril every 12 hours) for 4 weeks, and the control group (n = 20) received saline solution nasal spray as placebo in the same manner. Adenoid size and subjective symptoms were evaluated and compared between the 2 groups. Results: At the start of the experiment, there was no significant difference in the mean scores for any of the subjective symptoms (nasal obstruction, snoring, mouth breathing) between the 2 treatment groups. At the end of 4 weeks, statistically significant improvement was observed in total subjective symptom scores with mometasone treatment compared with placebo ( P &lt; .05). A significantly greater number of patients in the study group showed a reduction in adenoid size compared with the control group (70% versus 20%, P = .001). Conclusions: Treatment with mometasone furoate nasal spray causes a substantial improvement in nasal obstruction symptoms and reduction in size of adenoid in children with adenoidal hypertrophy and may obviate the need for surgery in these patients.

A double-blind randomized placebo-controlled trial of topical intranasal mometasone furoate nasal spray in children of adenoidal hypertrophy with otitis media with effusion

PurposeTo study the effects of topical intranasal mometasone furoate nasal spray for management of otitis media with effusion in children aged 2–12 years with adenoidal hypertrophy and its impact on change in quality of life. MethodA prospective randomized double blind interventional placebo control study was conducted. Hundred patients of endoscopic grade 3 or 4 adenoidal hypertrophy aged 2–12 years were enrolled in this study. Among these sixty two patients had persistent bilateral otitis media with effusion more than three months. These were randomly divided into two groups, group A and group B. Group A received mometasone nasal spray for six months and group B received saline nasal spray for the same period. Patients were evaluated with symptom, pure tone audiometry wherever possible, pneumatic otoscopic examination and tympanogram at 0, 8 and 24weeks. ResultsResolution of otitis media with effusion in study group (28 out of 30) was significantly higher as compared control group (16 out of 32) (p value 0.0004). A significant improvement in hearing and symptoms was seen in the study group (p<0.04). Statistically significant change in quality of life was seen with mometasone nasal spray (37.11) as compared to saline nasal spray (11.02) (p value 0.0001). ConclusionMometasone nasal spray appears to be effective for the treatment of otitis media with effusion in patients of adenoidal hypertrophy.

Anti-inflammatory effect of IL-37b in children with allergic rhinitis.

Background. Interleukin-37 (IL-37), a newly described member of IL-1family, functioned as a fundamental inhibitor of innate inflammatory and immune responses, especially its isoform IL-37b. Objective. This study was undertaken to evaluate the expression and regulation of IL-37b in children with allergic rhinitis (AR). Methods. Forty children with AR and twenty-five normal controls were included. The relationship between IL-37b and Th1/2 cytokines production in serum and nasal lavage was examined by enzyme-linked immunosorbent assay (ELISA). Peripheral blood mononuclear cells (PBMCs) were purified for in vitro regulation experiment of IL-37b. Intranasal mometasone furoate was given in AR children and IL-37b change after one-month treatment was detected using ELISA. Results. We observed significantly decreased IL-37b expression levels in both serum and nasal lavage compared to controls. IL-37b was negatively correlated with Th2 cytokines. Our results also showed that IL-37b downregulated Th2 cytokine expressed by PBMCs and this modulation was through mitogen-activated protein kinase (MAPK) and phosphatidylinositol 3-kinase (PI3K) pathway. We also found that intranasal mometasone furoate therapy can promote nasal IL-37b expression. Conclusion. IL-37b may be involved in Th2 cytokine regulation in AR and its expression was related to the efficacy of intranasal steroid therapy.

Effects of topical nasal steroids and diclofenac on the nasal mucosa during hyperbaric oxygen therapy: a double-blind experimental study

We aimed to evaluate nasal mucosal changes and efficiency of nasal steroids and diclofenac on nasal mucosa during hyperbaric oxygen (HBO) treatment. Forty adult Albino-Wistar rats were randomized into four groups. Group 1 (control group) (n = 10) not exposed to hyperbaric or enhanced oxygen concentrations; group 2 (HBO group) (n = 10) underwent only HBO treatment; group 3 (n = 10) received HBO and intranasal mometasone furoate (10 μl/day); group 4 (n = 10) treated with HBO and diclofenac sodium (10 mg/kg/day ip). Specimens of nasal mucosa were collected after sacrificing and dissection of animals. The specimens were processed for light microscopic evaluation, and then evaluated histopathologically for fibroblastic proliferation and inflammation. Regarding the scores of inflammation, the level of inflammation in the control group was significantly less severe than the other groups (p < 0.05). Evaluation of the fibrosis scores showed that the scores of both groups 2 and 4 were significantly increased (p < 0.05). There were no statistically significant differences between groups 2, 3, and 4 as for fibrosis and inflammation (p > 0.05). Chronic HBO treatment induced mild inflammation of the nasal mucosa. These effects cannot be prevented adequately by administration of nasal steroids and diclofenac.

A manic episode in a patient with stable bipolar disorder triggered by intranasal mometasone furoate

Sir, Intranasal corticosteroid sprays are a mainstay treatment for allergic rhinitis and other conditions. The usual drug prescription textbooks, such as the Physicians’ Desk Reference, do not mention mania as a possible adverse event. Confronted with a bipolar patient who developed a hypomanic episode after taking mometasone furoate, we briefly reviewed the literature on the topic of mania and nonsystemic corticosteroid therapy. We found three case reports published in the 1980s: one of an asthmatic child aged 5 who developed mania on inhaled budenoside [Lewis and Cochrane, 1983]; one of a 69-year-old patient who had previously presented prednisone-induced manic symptoms and developed mania on intranasal beclomethasone [Phelan, 1989]; and one of a 28-year-old known bipolar patient, who was stable and developed mania on intranasal beclomethasone [Goldstein and Preskorn, 1989]. We found two other studies reporting a possible link between intranasal corticosteroid sprays and mania: one was an online survey of 192 bipolar patients about possible triggers of affective episodes; antiallergic medication was a rarely reported possible trigger of mania [Proudfoot et al. 2012]; the other was a report of the International Pharmacovigilance Programme of the World Health Organization and reported seven cases of manic reactions attributed to intranasal corticosteroids, which were not described in further details [Pokladnikova et al. 2008]. We contribute to the literature with our case report.

The role of mometasone furoate nasal spray in the treatment of adenoidal hypertrophy in the adolescents: a prospective, randomized, cross-over study

Aim of this work is to find out whether the symptoms attributable to adenoid hypertrophy in adolescents may be treated with intranasal mometasone furoate (MF) application. To learn if adenoid hypertrophy in adolescents may decrease in size with intranasal MF. A prospective, double blind, randomized, cross-over study was conducted in 28 subjects (12-18 years) with adenoidal hypertrophy. Subjects used intranasal MF or placebo for a duration of 6 weeks with a wash out period of 3 weeks. Subjective symptoms and adenoid size were evaluated. At the initiation of the study, there was no significant difference between the mean symptom scores for any of the sinonasal symptoms between the two treatment groups. There was significant improvement in total subjective symptoms (nasal blockage, rhinorrhea, cough, snoring and disruption of quality of life scores) with MF compared with placebo. Analysis of the symptoms separately showed a significant positive effect of MF on all symptoms except for rhinorrhea. Nasal endoscopic evaluation failed to demonstrate any difference in the reduction of the adenoid size between the two groups. MF has significant advantage over placebo for the symptoms attributable to adenoid hypertrophy in adolescents.

Efficacy of mometasone nasal spray in the treatment of otitis media with effusion in the pediatric age group: A preliminary study

Aims: To study the efficacy of mometasone furoate monohydrate topical nasal spray in the treatment of otitis media with effusion (OME) in children aged between 4 and 15 years. Thus, by comparative analysis of results, at 0 and 6 weeks of using mometasone nasal spray, its efficacy in improving the clinical and audiological status of children with OME is assessed. Materials and Methods: A prospective, clinical study carried out on 22 children aged between 4 and 15 years who had attended our Department of Otolaryngology in a tertiary care hospital from January 2008 to May 2009. Results: The efficacy of mometasone furoate monohydrate topical nasal spray in the resolution of middle ear fluid in children aged between 4 and 15 years with OME in this study group was observed to be significant (52.7%). A significant improvement in the overall symptoms was seen in the treatment group. There was good improvement in the audiological status also. Conclusion: Topical steroids can be an alternative to surgery in controlling OME. However, these results are only short-term; a long-term follow-up is necessary. Topical intranasal mometasone furoate therapy can be considered a good therapeutic option to OME. Nasal administration of this steroid is safe, reproducible, easily performed, and well tolerated by pediatric patients.

Is It Really Necessary to Delay Intranasal Steroid Treatment after FESS? An Animal Study

The aim of this study is to investigate the effect of early intranasal steroid administration on wound healing after sinus surgery. Randomized, placebo-controlled, blinded animal study. Animal laboratory. Forty-two male New Zealand rabbits underwent bilateral 3-mm punch resection of the concha nasalis ventralis. The animals were divided into 3 groups: saline, late steroid, and early steroid. The saline group received saline drops, the late steroid group received saline drops for 7 days followed by intranasal mometasone furoate 50 µg/nostril/d, and the early steroid group received intranasal mometasone furoate (same dose) starting on postoperative day 1. The animals were sacrificed on postoperative days 10 and 21. Left nasal specimens were examined histopathologically with hematoxylin-eosin and matrix metalloproteinase-9 (MMP-9) stains. Right nasal specimens were examined with high-performance liquid chromatography, and hydroxyproline levels were measured as mg/g in wet tissue. Late steroid and early steroid groups were similar with regard to MMP-9 staining on days 10 and 21. On day 10, the early steroid group revealed significantly intense MMP-9 staining when compared with the saline group, and the late steroid and early steroid groups revealed significant fibrosis when compared with the saline group. Hydroxyproline levels were similar in all groups on day 10. The early steroid group revealed significantly higher hydroxyproline levels when compared with the late steroid group on day 21. Our findings showed that early intranasal steroid administration after sinus surgery in an animal model has no detrimental effects with regard to wound-healing parameters.

Mometasone Furoate for Adenoidal Hypertrophy in Adolescents

Objective: 1) To find out whether the symptoms attributable to adenoid hypertrophy in adolescents may be treated with intranasal mometasone furoate (MF) application. 2) To learn if adenoid hypertrophy in adolescents may decrease in size with intranasal MF. Method: A prospective, double-blind, randomized, crossover study was conducted in 28 subjects (12-18 years) with adenoidal hypertrophy. Subjects used intranasal MF or placebo for a duration of 6 weeks with a washout period of 3 weeks. Subjective symptoms and adenoid size were evaluated. Results: At the initiation of the study, there was no significant difference between the mean symptom scores for any of the sinonasal symptoms between the 2 treatment groups. Placebo users had no statistically significant reduction in their sinonasal symptoms ( P &gt; .05 for all) other than snoring ( P = .011). MF users had a statistically significant reduction in all symptoms ( P &lt; .05 for all) other than coughing ( P = .527). There was a significant difference between the 2 treatment groups in the mean posttreatment scores for total subjective symptom scoring and rhinorrhea ( P = .031, P = .012 resp). There was no significant difference in baseline endoscopy scores between the 2 treatment groups ( P = .317). There was a significant reduction in nasal endoscopy scores in the MF group compared to placebo group ( P = .034). Conclusion: MF may have some advantage over placebo for the symptoms attributable to adenoid hypertrophy in adolescents. Intranasal MF decreases the size of the adenoid hypertrophy in this group of patients.

Effects of intranasal mometasone furoate on itchy ear and palate in patients with seasonal allergic rhinitis

BackgroundIntranasal steroids relieve nasal symptoms and ocular itch in allergic rhinitis. Itchy ear and palate are also common and bothersome symptoms but have received little attention in clinical trials of allergic rhinitis. ObjectiveTo ascertain the efficacy of mometasone furoate nasal spray in alleviating itchy ear and palate in seasonal allergic rhinitis. MethodsData were pooled from 4 randomized, double-blind, placebo-controlled trials of mometasone furoate nasal spray, 200 μg/d. Participants rated ear and palate itching from baseline through treatment day 15 as follows: 0, none; 1, mild; 2, moderate; and 3, severe. ResultsA total of 962 study participants received mometasone furoate nasal spray or placebo. Baseline least squares mean itchy ear and palate score was 1.81 for participants receiving mometasone furoate nasal spray (n = 480) and 1.85 for participants receiving placebo (n = 482). Mometasone furoate nasal spray was associated with a greater decrease in itchy and ear palate score vs placebo during the 15-day study period (least squares mean change, −0.73 vs −0.45; P < .001). The difference reached significance on day 2 and persisted through day 15 (P ≤ .01 for each day). Results were similar in a subgroup of patients (n = 305) with moderate-to-severe symptoms at baseline. Adverse events with mometasone furoate nasal spray were similar to those observed in other studies of intranasal steroid therapy. ConclusionThese preliminary findings suggest that mometasone furoate nasal spray effectively treats itchy ear and palate in individuals with seasonal allergic rhinitis. Itchy ear and palate is a relevant end point for future clinical trials of allergic rhinitis.

Early Interventional Treatment with Intranasal Mometasone Furoate in Japanese Cedar/Cypress Pollinosis: A Randomized Placebo-Controlled Trial

Little is known about the safety and effectiveness of early interventional treatment (EIT) with intranasal corticosteroids for seasonal allergic rhinitis. We designed a double-blinded, randomized, placebo-controlled 12-week trial of EIT with mometasone furoate nasal spray (MFNS) for Japanese cedar/cypress pollinosis (JCCP). A total of 50 JCCP patients received MFNS (200μg once daily: n = 25) or placebo (n = 25) starting on February 1, 2010. Treatments continued until the end of April. The primary endpoint was the comparison of the total nasal symptom score (TNSS) between the MFNS and placebo groups. The secondary endpoints included comparisons of QOL, daytime sleepiness, nasal ECP levels, and safety. Continuous dispersion of Japanese cedar pollen began on February 22. Although the placebo group showed a significant worsening of symptoms after the start of the continuous dispersion, no worsening occurred in the MFNS group. A significant difference in the TNSS between the two groups was seen starting at 4 weeks after the treatment. Similar results were seen for QOL and sleepiness. Nasal ECP levels in March were significantly lower in the MFNS group. A total of 56% of the MFNS group progressed to a persistent allergic rhinitis state in accordance with the ARIA classification, as opposed to 84% of the placebo group. MFNS was well tolerated, and the plasma cortisol concentrations were similar between the two groups. EIT with MFNS for JCCP is both safe and effective. This treatment can potentially lessen symptoms and help pollinosis patients remain in the intermittent state.

Efficacy and long-term safety of mometasone furoate nasal spray in children with perennial allergic rhinitis

Background:Allergic rhinitis (AR) affects up to 40% of children by age 6 years. Perennial AR (PAR) causes sleep disturbance, diminishes concentration in school, impairs psychosocial functioning, and reduces quality of life. This study evaluated efficacy and long-term safety of the intranasal corticosteroid mometasone furoate nasal spray (MFNS) in children with PAR.Methods:This study comprised a double-blind, 4-week efficacy and safety period followed by a 6-month, open-label safety period. Primary efficacy variable during the double-blind period was mean change in physician-evaluated total nasal symptom score (TNSS) from baseline to day 15. Other efficacy variables during this phase included subject-evaluated TNSS, individual nasal symptoms, and total symptom score (TSS, nasal and non-nasal symptoms, summed). Physician-evaluated improvement in overall condition of PAR was assessed during the open-label period. Adverse events (AEs) were monitored throughout.Results:Subjects aged 3–11 years with PAR (n = 381) were randomized to MFNS 100 µg (n = 190) or placebo (n = 191) daily for 4 weeks; 357 subjects continued into the open-label period, receiving MFNS only. Between baseline and day 15, significantly greater mean changes were seen with MFNS-treated patients than placebo in physician-evaluated TNSS (−2.8, −39%, vs. −2.2, −32%; p = 0.02). Statistically significant improvements in MFNS versus placebo were reported for subject-evaluated TNSS, TSS, and individual nasal symptom scores (p ≤ 0.03 for all).Improvement continued through the open-label period. Subjects treated with MFNS in both periods experienced a 45% further reduction in TSS in this study phase, while those who switched from placebo to MFNS saw a further 49% decrease. MFNS was well-tolerated in both periods. The most frequently reported treatment-related AEs during the double-blind period for MFNS and placebo, respectively, were epistaxis, seven (4%) and nine (5%); sneezing, five (3%) and seven (4%); headache, six (3%) and five (3%). During the open-label period, the AEs reported most often were epistaxis 37 (10%), headache nine (3%), and rhinitis 12 (3%).Limitations:Studies in children present unique challenges because subjects are too young to grasp subjective concepts such as symptom severity, especially as rated on a numbered scale. In addition, the 6-month extension of the placebo-controlled phase used a single agent. It is also possible that subjects’ symptoms could have abated independent of mometasone furoate treatment.Conclusion:MFNS 100 µg/day effectively reduces TNSS, TSS (including ocular symptoms), and individual symptoms associated with PAR and is well-tolerated for up to 6 months in children aged 3–11 years with a safety profile similar to placebo.

Intranasal mometasone furoate therapy for allergic rhinitis symptoms and rhinitis-disturbed sleep

Allergic rhinitis (AR) and related nasal congestion cause rhinitis-disturbed sleep (RDS). Intranasal corticosteroids reduce nasal congestion and improve sleep quality in AR but have not been extensively studied in RDS. To evaluate the efficacy of mometasone furoate nasal spray (NS) on nasal symptoms, nasal patency, sleep variables, quality of life, and daytime functioning in perennial AR (PAR) and concomitant RDS. In this double-blind 4-week study, 30 adults with PAR and moderate RDS were randomized 2:1 to receive mometasone furoate NS, 200 microg, or placebo each morning. The primary end point was the apnea-hypopnea index. Secondary outcome measures included changes in total nasal symptom score (TNSS), nighttime symptom score, daytime peak nasal inspiratory flow, nighttime flow limitation index, Rhinoconjunctivitis Quality of Life Questionnaire-Standardized (RQLQ-S) score, Epworth Sleepiness Scale score, and Work Productivity and Activities Impairment-Allergy Specific (WPAI-AS) questionnaire score. Analysis of covariance was used for all efficacy end points. The apnea-hypopnea index at study end was not statistically significantly different between groups. However, mometasone furoate NS therapy significantly improved morning (P = .04) and evening (P = .01) TNSSs, morning (P = .049) and evening (P = .03) nasal obstruction/blockage/congestion, daily peak nasal inspiratory flow (P = .03), flow limitation index (P = .02), Epworth Sleepiness Scale score (P = .048), RQLQ-S score (P = .03), and 2 of 5 WPAI-AS domains. Among patients receiving mometasone furoate NS, TNSS improvements were significantly correlated with improved work- and non-work-related productivity. In patients with PAR and RDS, mometasone furoate NS use improved nasal symptoms, sleepiness, and impairment in daily activities. Correlated reduced nasal symptoms and improved performance suggest that improving AR symptoms with mometasone furoate NS administration can benefit sleep and daytime functioning.